Proprioceptive Training,Balance,Motor Function,Spastic Cerebral Palsy Patient

March 2, 2022 updated by: University of Lahore

Effects of Proprioceptive Training on Balance and Motor Function in Children With Spastic Hemiplegic Cerebral Palsy

Study Design: Randomized Controlled Trial Settings: Study will be conducted at Mobility quest clinic, Lahore Sample size:37 in each group Control group receive : Routine physical therapy Experimental group receive : Routine physical therapy+proprioceptive training

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Control group : Group A will be control group which will be of 60 minutes each session. The routine physical therapy will include

  • Passive stretching exercises
  • Weight bearing exercises
  • Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.

Experimental group : Routine physical therapy+proprioceptive training. Group B will be given proprioceptive training. Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes each session.

The Proprioceptive training included the following exercises.

  • Stair climbing up and down (a regular 3 steps staircase).
  • Standing with feet approximately shoulder-width apart and arms extended out slightly forward lower than the shoulder, then lifting both heel off the floor and to hold the position for 10 seconds, followed by climbing regular steps staircase. This procedure will be performed with eyes closed also.
  • Standing with feet side by side & holding the arms in same position as described above, one foot is placed on the inside of the opposing ankle and to hold the position for 10 seconds. Followed by climbing regular steps staircase. This procedure will be performed will be eyes closed also.
  • To perform one leg standing with one foot raised to the back and to maintain the position for minimum 3 seconds. This procedure will be performed with eyes closed also.
  • Same exercise as above performed but with one foot raised to the front. This procedure will be then performed with eyes closed.
  • Walking heel to toes.
  • Rising from a standard chair (4 times) without arm support. For proprioception Swiss ball will be use as a modality and it will be performed passively by the physical therapist.For this physical therapist will be on the front of the subject different activities will be performed in different positions.
  • For posture control development child will sit on the ball and ball will be rolled from side to side.
  • Extension rotation and flexion rotation will be performed to facilitate trunk rotation.
  • Trunk rotation will be performed with stabilized pelvis and hip. Reaching activities will be done in different directions that will allow the child to work on trunk and lateral weight shifting.
  • Position the child supine on the ball with the feet to the floor. Hold through the lower abdominals to stabilize them on to the ball. Now facilitate through one arm and bring the child diagonally up to stance.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 38000
        • Recruiting
        • Mobility Quest Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Children with spastic hemiplegic cerebral palsy ranging from 8 to 14 years. 19

    • Both genders.
    • Gross motor function level II.
    • Children who can follow commands.
    • Pre-diagnosed cerebral palsy subjects of cerebral palsy confirmed by an expert pediatrician.

Exclusion Criteria:

  • • The children with cerebral palsy having co-morbid conditions and contractures that can interfere with recovery will be excluded.

    • The children having severe mental retardation because of difficulty in understanding commands.
    • Any red flag signs (tumor, fracture, metabolic diseases, prolong history of steroidal use.
    • Patients having ventriculoperitonel shunt.
    • Patients unable to travel frequently or as per call from rehab center.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Proprioceptive Training

Proprioceptive training will include : Stair climbing up and down,Standing with feet side by side and up and down,one leg standing,Walking heel to toes,Rising from a standard chair.

Swiss ball activity will be performed passively by the physical therapist in which child will sit on the ball and ball will be rolled from side to side,Extension rotation and flexion rotation will be performed to facilitate trunk rotation that will be performed with stabilized pelvis and hip.

Routine physical therapy will include passive stretching ,strength training and weight bearing exercises. total session will be of 60 minutes.
Other: Proprioceptive training

Proprioceptive Training will include some active exercises such as stair climbing up and down,one leg standing,Walking heel to toes,rising from a standard chair.

And swiss ball training will be applied passively by therapist in which child will sit on the ball and ball will be rolled from side to side,Extension rotation and flexion rotation will be performed to facilitate trunk rotation,Trunk rotation will be performed with stabilized pelvis and hip.

Other Names:
  • Routine physical therapy
Other: Routine Physical therapy

Group A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include

  • Passive stretching exercises
  • Weight bearing exercises
  • Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.
PLACEBO_COMPARATOR: Routine Physical Therapy

Group A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include

  • Passive stretching exercises
  • Weight bearing exercises
  • Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.
Other: Routine Physical therapy

Group A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include

  • Passive stretching exercises
  • Weight bearing exercises
  • Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: 12 weeks
balance will be measured by pediatric balance scale.The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
12 weeks
Motor Function
Time Frame: 12 weeks
Motor function will be measured by Gross Motor Function Measure 88 scale.It includes scoring key in which 0 means does not initiate and 3 means completely performs the exercise.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Kinza Amin, MSPTN*, Univerity of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 23, 2021

Primary Completion (ANTICIPATED)

August 16, 2022

Study Completion (ANTICIPATED)

August 26, 2022

Study Registration Dates

First Submitted

February 12, 2022

First Submitted That Met QC Criteria

February 12, 2022

First Posted (ACTUAL)

February 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-UOL-FAHS/1079/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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